FDA.reportPublic FDA data

BETHKIS

Product NDC
10122-820
11-digit product format
101220820
Labeler code
10122
Product ID
10122-820_32442297-00c4-4800-b7c4-1e2e290f3162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Chiesi USA, Inc.
Application
NDA201820
Marketing category
NDA
Marketing start
2013-04-15
Substance
TOBRAMYCIN
Active strength
300 mg/4mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BETHKIS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN300 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui1314763, 1314768

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-820-04BETHKIS4 in 1 POUCHSOLUTION418
10122-820-04BETHKIS4 mL in 1 AMPULESOLUTION418
10122-820-28BETHKIS4 in 1 POUCHSOLUTION418
10122-820-28BETHKIS7 in 1 CARTONSOLUTION718
10122-820-56BETHKIS4 in 1 POUCHSOLUTION418
10122-820-56BETHKIS14 in 1 CARTONSOLUTION1418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-820-04ML - Milliliter10122-82082f319d6-24a6-4066-8730-cc94c62d9cc812013-10-17
10122-820-28ML - Milliliter10122-820b53c2773-8ae8-4bb0-b6eb-01c786602cb812014-06-03
10122-820-56ML - Milliliter10122-82032f0afe2-1cd8-4c9e-a73e-1932b8457fcc12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCINACTIVE INGREDIENTVZ8RRZ51VKBETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]6
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKBETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]6
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFBETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RBETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-820BETHKIS (TOBRAMYCIN) SOLUTION [CHIESI USA, INC.]18Current NDC, Legacy NDC, 6 package rows20230223_1cd3d47b-025f-4705-9daf-cf07725ec223.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1314768Bethkis 300 MG in 4 ML Inhalation SolutionPSN1cd3d47b-025f-4705-9daf-cf07725ec22318
1314763tobramycin 300 MG in 4 ML Inhalation SolutionPSN1cd3d47b-025f-4705-9daf-cf07725ec22318
1314768tobramycin 75 MG/ML Inhalation Solution [Bethkis]SBD1cd3d47b-025f-4705-9daf-cf07725ec22318
1314763tobramycin 75 MG/ML Inhalation SolutionSCD1cd3d47b-025f-4705-9daf-cf07725ec22318
1314768Bethkis 300 MG per 4 ML Inhalation SolutionSY1cd3d47b-025f-4705-9daf-cf07725ec22318
1314768Bethkis 75 MG/ML Inhalation SolutionSY1cd3d47b-025f-4705-9daf-cf07725ec22318
1314763tobramycin 300 MG per 4 ML Inhalation SolutionSY1cd3d47b-025f-4705-9daf-cf07725ec22318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10122-820-04101220820044 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE4 ampule2013-04-15NoNoHistorical
10122-820-28101220820287 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE7 pouch2013-04-150000-00-00NoNoCurrent
10122-820-561012208205614 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE14 pouch2013-04-150000-00-00NoNoCurrent